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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021441
Company: HALEON US HOLDINGS

Products on NDA 021441

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADVIL ALLERGY SINUS	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG;200MG;30MG	TABLET;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021441

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2002	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21441_Advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-441_Advil%20Allergy-Sinus_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-441_Advil.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2021	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021441Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021441Orig1s016ltr.pdf
03/24/2017	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021441Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021441Orig1s012ltr.pdf
08/31/2010	SUPPL-11	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021441s011ltr.pdf
05/19/2009	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021441s009ltr.pdf
06/23/2008	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021441s008ltr.pdf
02/27/2006	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021441s005ltr.pdf
07/09/2004	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21441slr001_advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21441slr001ltr.pdf

Labels for NDA 021441

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2021	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021441Orig1s016lbl.pdf
03/24/2017	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021441Orig1s012lbl.pdf
07/09/2004	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21441slr001_advil_lbl.pdf
12/19/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21441_Advil_lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

ADVIL ALLERGY SINUS

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 2MG;200MG;30MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL ALLERGY SINUS	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG;200MG;30MG	TABLET;ORAL	Over-the-counter	Yes	021441	HALEON US HOLDINGS

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